Intended use
TSH determination is the most sensitive indicator for the diagnosis of primary hypothyroidism. The Fluorescent immunoassay TSH POCT kit is used for quantitative detection of human thyroid-stimulating hormone (TSH) level, which plays an auxiliary role in clinical evaluation of thyroid status.
Summary
Thyroid-stimulating hormone (TSH) is the main factor that regulates the growth of thyroid cells and the synthesis and secretion of thyroid hormones.Thyroid stimulating hormone (TSH) is a glycoprotein hormone of 28KD secreted by the anterior pituitary gland. TSH has two subunits, namely α and β. The α subunit of TSH is similar to the α subunit found in the LH, FSH and hCG glycoprotein hormones. The β subunit however, is specific and differs from hormone to hormone.
TSH stimulates positively the production of thyroid hormones T4 and T3. Circulating T4 and T3 regulate the TSH secretion by negative feedback. TSH production is also under the positive control of thyrotropin-releasing hormone (TRH), which is secreted by hypothalamus.
Measurement of serum TSH is generally regarded as the most sensitive indicator available for the diagnosis of primary and secondary hypothyroidism. In primary hypothyroidism, where there is impaired production of thyroid hormones, the TSH level is typically highly elevated. In secondary or tertiary hypothyroidism where the thyroid hormones are low as a consequence of pituitary or hypothalamic lesions, the TSH level is usually low.
Further, a sensitive TSH assay is also able to differentiate the hyperthyroidism from the euthyroid population. TSH is typically suppressed to subnormal levels in most hyperthyroidism.
It is recommended to assay both TSH and thyroid hormones for the clinical assessment of thyroid status. This Fluorescent Immunoassay TSH POCT kit can reflect the status of thyroid function and is helpful for screening, diagnosis, evaluation of treatment effect and prognosis of thyroid diseases.
PRODUCT PARAMETER
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TEST PARAMETER |
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Method |
Microfluidic Fluorescent Immunoassay |
Test |
LYOFIA® TSH |
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Format |
Cassette |
Reaction Time |
10min |
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Linearity |
0.1mIU/L～150mIU/L |
Reference Interval |
0.34～5.60mIU/L |
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Sample |
WB / S / P |
Certificate |
CE / NMPA |
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ORDERING |
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Cat. No. |
LMTHTS25 |
Applicable analyzer |
LYOFIA-I, LYOFIA 8, |
Kit Size |
25T |
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Cat. No. |
LATHTS25 |
Applicable analyzer |
LYOFIA 100 (Full-Automatic) |
Kit Size |
25T |
APPLICATION SCENARIOS
Hospitals
Laboratory
Clinics
Ambulance
Cardiology
Pediatrics
Emergency
CSC
FAQ
Q:Can the kit be reused?
A:Can’t be reused. It is a one-time use of in vitro diagnostic reagents.
Q: What range is the linearity?
A:The linear interval of the kit is 0.1mIU/L～150mIU/L.
Q:Are you a manufacturer or a trading company?
A:We are a company integrating R&D, production and sales.
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